Manages postherpetic neuralgia. ANDA 203934, held by Zydus Pharms. Gabapentin.
As of Nov 14, 2026, ANDA 203934 (Gabapentin), held by Zydus Pharms, was first approved by FDA on Jan 24, 2024, with 1 approved supplement and 0 published complete response letters.
Gabapentin tablet is indicated for the management of postherpetic neuralgia. Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Gabapentin tablet is indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration (see Warnings and Precautions).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 24, 2024 | Original application | Approved |
| Gabapentin300MG · tablet;oral | Gabapentin | Rx |
| Gabapentin600MG · tablet;oral | Gabapentin | Rx |
| Gabapentin450MG · tablet;oral | Gabapentin | Rx |
| Gabapentin750MG · tablet;oral | Gabapentin | Rx |
| Gabapentin900MG · tablet;oral | Gabapentin | Rx |
| Jul 17, 2026 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 24, 2024 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
